APPLICATION
ANDA086742
TYPE
ANDA
ORIGINAL APPROVAL
1981-11-05
LATEST ACTION
1999-06-08
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
CHOLEDYL SADiscontinued
OXTRIPHYLLINE 600MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
1999-06-08Manufacturing (CMC) · Supplement 19AP
1999-06-08Manufacturing (CMC) · Supplement 18AP
1999-06-08Labeling · Supplement 20AP
1998-02-24Manufacturing (CMC) · Supplement 16AP
1993-07-19Labeling · Supplement 13AP
1992-08-12Manufacturing (CMC) · Supplement 12AP
1991-10-18Labeling · Supplement 3AP
1991-08-21Manufacturing (CMC) · Supplement 9AP
1990-11-06Bioequivalence · Supplement 10AP
1988-10-13Bioequivalence · Supplement 7AP
1984-01-10Manufacturing (CMC) · Supplement 6AP
1984-01-10Manufacturing (CMC) · Supplement 4AP
1984-01-10Manufacturing (CMC) · Supplement 2AP
1981-11-05OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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